Tag: supreme-court

WASHINGTON The Supreme Court on Monday turned away two Covid-related appeals brought by Children's Health Defense, the anti-vaccine group founded by independent presidential candidate Robert F. Kennedy Jr.

The decision by the justices not to hear the cases leaves in place lower court rulings against the group.

One case challenged the Food and Drug Administration's emergency authorization of Covid-19 vaccines in December 2020, while the other was brought against Rutgers University in New Jersey over its Covid-19 vaccine mandate.

In the FDA case, the group claimed in court papers that Covid vaccines were "ineffective and lacked proper vetting." The New Orleans-based 5th U.S. Circuit Court of Appeals found that Kennedy's group did not have legal standing to sue.

In the Rutgers dispute, the Philadelphia-based 3rd U.S. Circuit Court of Appeals concluded that the plaintiffs "have not stated any plausible claim for relief."

Kennedy himself took leave from the group in April 2023 to run for president. He failed to make inroads in the Democratic primaries and is now running as an independent.

On the campaign trail he has mostly downplayed his anti-vaccine activity, but in November he spoke at a Children's Health Defense conference.

Kennedy is listed as a lawyer on the Rutgers filing at the Supreme Court despite his leave of absence from the group.

In a separate vaccine-related case, the court also turned away a challenge to Connecticut's decision to repeal a religious exemption for school vaccinations.

Lawrence Hurley covers the Supreme Court for NBC News.

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Supreme Court rejects appeals brought by RFK Jr.-founded anti-vaccine group over Covid shots - NBC News

FDA, DOJ Scrutinized Over Inaction on Youth Vaping Crisis

In a rare bipartisan effort, the Senate Judiciary Committee grilled the FDA and the Department of Justice for their perceived inaction on the youth vaping crisis amid the surge in flavored e-cigarette sales, according to CNN. Despite a court mandate to regulate e-cigarette products by September 2021, the FDA has struggled to keep pace with the influx of applications, authorizing only 23 products so far. Senators emphasized the urgent need for decisive action to remove illegal, youth-targeted flavored vapes from the market and criticized the FDA for not leveraging its enforcement capabilities more effectively.

Moderna's Next-Generation COVID-19 Vaccine Outperforms Current Shot in Efficacy

Moderna's latest COVID-19 vaccine demonstrated superior efficacy in a late-stage trial involving over 11,000 participants aged 12 years and older, outperforming the existing Spikevax shot, particularly in adults, according to Reuters. Designed for enhanced stability, the new vaccine can be stored in refrigerators, addressing distribution challenges in developing countries. The company is also exploring a combination vaccine for COVID-19 and flu, aiming for a potential market launch as early as the next autumn respiratory season.

Supreme Court Upholds Access to Key Abortion Drug

The US Supreme Court rejected a lawsuit challenging the FDAs approach to regulating the abortion pill mifepristone, according to CNN. The decision will allow the pills to be mailed to patients without an in-person doctors visit. The ruling is considered a significant victory for abortion rights advocates amidst ongoing national debates and legal battles over reproductive rights.

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What We're Reading: Youth Vaping Crisis; New COVID-19 Vaccine Superior to Current Shot; Supreme Court Upholds ... - AJMC.com Managed Markets Network

CHELAN Four years after the COVID-19 pandemic began, the popular Chelan waterpark Slidewaters has agreed to pay a reduced fine for refusing to close its doors during the opening months of the public health emergency.

Washingtons Department of Labor and Industries fined the park more than $9,600 in July 2020 for reopening despite the governors order to close gathering places throughout the state.

The conservative nonprift Freedom Foundation stepped up to provide legal representation to the waterpar, which went on tofight the COVID rules in federal courtand lose in every venue as courts upheld Gov. Jay Inslee's emergency powers as constitutional. The U.S. Supreme Court refused to hear the park's final appeal.

But the administrative fine remained unpaid, and was under appeal in Chelan County Superior Court until this week. Slidewaters and L&I agreed to a reduced penalty of just over $7,200, and asked the judge to dismiss the case.

Slidewaters must pay its fine in scheduled installments by July 2025.

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Slidewaters agrees to fine for COVID-19 closure violation - NCWLIFE News

The North Carolina Supreme Court will consider the case of a Guilford County teenager who was vaccinated against COVID-19 in 2021 despite his objections and without parental consent.

A court order Thursday confirmed that the high court will take up the case of Tanner Smith, who was 14 when he faced the forced vaccination. Smiths mother, Emily Happel, is also a plaintiff in the lawsuit against the Guilford County school board and Old North State Medical Society.

Lower courts have ruled against the mother and son. A unanimous state Court of Appeals panel ruled in March that a federal law, the Public Readiness and Emergency Preparedness Act, protected the school board and medical group from legal liability linked to the vaccination.

Thursdays court order signaled that Supreme Court justices will consider a single issue from Happel and Smiths appeal: Whether the trial court and the Court of Appeals erred when they determined that the PREP Act provided immunity to the defendants for constitutional violations and pre-empted all state law claims.

The case has attracted attention from eight Republican members of North Carolinas House of Representatives. They filed a brief on April 12 urging the high court to take the case.

They have a special interest in protecting the fundamental rights of the parents they represent and for whom the General Assembly has recently enacted legislation on the very subject embraced by this appeal, wrote Tyler Brooks of the Thomas More Society, who represents the eight legislators.

As members of the General Assembly, they have a unique role in ensuring that local governmental bodies, particularly those charged with public education or who otherwise interact with children, abide by and are governed according to North Carolina state law, Brooks added. In this same vein, they further have a strong interest in ensuring that the enactments of the General Assembly are upheld against erroneous findings of federal preemption, as occurred in the instant case.

The Guilford school board and Old North State Medical Society filed separate documents asking North Carolinas highest court not to take the case.

The school boards court filing asked the court to reject claims from Happel and Smith on the grounds that the alleged constitutional questions are not real and substantial and that the subject matter of this case does not involve legal principles of major significance to the jurisprudence of this State or raise issues of significant public interest.

[T]he direct issue before the Court of Appeals is not a substantial constitutional question rather, it is a straightforward application of federal statutory immunity, which applies to the same degree to state law claims and state constitutional claims, and which is not at all an issue of first impression, the Guilford schools lawyers wrote. In fact, the idea of federal law overriding contrary state constitutional provisions appears in the U.S. Constitution itself, which expressly states that federal law supersedes both contrary state laws and state constitutions.

Even the specific idea of the PREP Act immunizing against constitutional claims is not a new one, the court filing added. Guilfords brief cited a 2024 decision from the 9th US Circuit Court of Appeals holding that, through the PREP Act, Congress expressly foreclosed federal constitutional claims related to covered countermeasures.

Happel and Smith filed a petition on April 5 asking the states highest court to take their case.

The pandemic that occurred from 2020-2022 caused a seismic shift in the social, medical, political, and legal landscape of not only the State of North Carolina, not only the United States, but the world as a whole, wrote lawyer David Steven Walker. How the government chose to deal with the pandemic, especially concerning the administration of vaccines that had been granted emergency use authorizations, was and is a hotly contested issue, one that is certainly of significant public interest.

This public interest is even more significant when the issue revolves around the vaccination of a minor and the allegation that neither the minor nor the minors parent consented to the administration of the vaccine, Walker added.

The case deals with the interplay between duty of the courts of North Carolina to remedy constitutional and other legal violations and a federal law that defendants purport forecloses that opportunity, Walker wrote.

The trial court and the Court of Appeals interpreted the PREP Act so broadly as to shield nearly every act, no matter how egregious, from any legal consequence, according to the petition. Further, the Court of Appeals and the trial courts decision rendered totally useless N.C. Gen. Stat. 90-21.5(a1) which prohibited the very acts committed by defendants. It is now a law of aspiration, with no consequence for its blatant violation.

The quoted state law NCGS 90-21.5(a1) says, Notwithstanding any other provision of law to the contrary, a health care provider shall obtain written consent from a parent or legal guardian prior to administering any vaccine that has been granted emergency use authorization and is not yet fully approved by the United States Food and Drug Administration to an individual under 18 years of age.

The Appeals Court issued a unanimous March 5 decision against the mother and son despite labeling the forced vaccination egregious.

Plaintiffs argue the trial court erred in determining that the PREP Act is applicable to this case and provides immunity to both Defendants, Judge April Wood wrote. Due to the sweeping breadth of the federal liability immunity provision in the PREP Act, we are constrained to disagree.

Bound by the broad scope of immunity provided by the PREP Act, we are constrained to hold it shields Defendants, under the facts of this case, from Plaintiffs claims relating to the administration of the COVID-19 vaccine, Wood added.

In August 2021, Smith was a 14-year-old Western Guilford High School football player. His family learned in a letter from the Guilford schools that Smith might have been affected by a COVID-19 cluster involving the team. He would not be allowed to return to practice until getting a COVID test.

Free testing would be provided at Northwest Guilford High School. The letter indicated ONS Medical Society would conduct the testing and consent for testing is required, Wood wrote.

Smiths stepfather drove him to the testing site and waited outside the building. The teenager was asked to fill out a form while a clinic worker tried unsuccessfully to contact his mother. Smith and his family didnt know the clinic also provided COVID-19 vaccine shots.

After failing to make contact with Tanners mother, one of the workers instructed the other worker to give it to him anyway. Tanner stated he did not want a vaccine and was only expecting a test, but one of the workers administered a Pfizer COVID-19 vaccine to him, Wood wrote.

Happel and Smith filed suit in August 2022. A trial judge dismissed the case in March 2023.

Appellate judges ruled that both the school board and medical society were covered by the federal PREP Act. A declaration from the secretary of the US Department of Health and Human Services in March 2020 offered protection related to the COVID-19 vaccine.

[W]e hold ONS Medical Society is a covered person as a program planner that administered a vaccine clinic, and individually administered vaccines to individuals. The declaration clearly provides that a program planner may be a private sector employer or community group when it carries out the described activities including administration of a covered countermeasure, Wood wrote.

The same law also applied to the Guilford school board. We are convinced by the Secretarys interpretation in the declaration that a covered person under the PREP Act includes a state or local government . . . [that] provides a facility to administer or use a Covered Countermeasure. We hold this language includes the Board, which provided a facility Northwest Guilford High School for the administration of the COVID-19 vaccines, Wood wrote.

Wisely or not, the plain language of the PREP Act includes claims of battery and violations of state constitutional rights within the scope of its immunity, and it therefore shields Defendants from liability for Plaintiffs claims, Wood added.

The Appeals Court noted that North Carolinas General Assembly amended state law in 2021 to require parental consent before a vaccine granted emergency use authorization may be administered to a minor.

Its intent is to prevent the egregious conduct alleged in the case before us, and to safeguard the constitutional rights at issue Emilys parental right to the care and control of her child, and Tanners right to individual liberty, Wood wrote. Notwithstanding, the statute remains explicitly subject to any other provision of law to the contrary under the broad provision preempting state law in the PREP Act.

The PREP Act provides only one exception for a Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct. Because Plaintiffs have not made any such allegations in their complaint, we are constrained to conclude the PREP Act preempts the protections provided by state law, Wood wrote.

Judges Allegra Collins and Jeff Carpenter joined Woods decision.

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State's high court will take up teen's forced COVID vaccination case - Carolina Journal

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President Biden appeared to claim he was vice president during the coronavirus pandemic and that former President Barack Obama had dispatched him to Detroit to help with the response.

In comments first reported by the New York Post, Biden addressed an NAACP campaign event in Michigan Sunday night, where he repeatedly railed against his presumptive Republican opponent, former President Trump, while offering an aside about the contagion which began in 2019 while the latter was in office.

"When I was vice president, things were kind of bad during the pandemic," Biden said near the beginning of his remarks.

"And, what happened was Barack said to me: Go to Detroit help fix it."

BIDEN BIZARRELY ENDS CONNECTICUT SPEECH WITH GOD SAVE THE QUEEN, MAN

Going on to reference Detroit Democratic Mayor Mike Duggan, who was seated to Biden's right, the president continued, "Well, the poor mayor he's spent more time with me than he ever thought he's going to have to."

Duggan then rose and shook Biden's hand.

The pandemic, numbered COVID-19 due to global health officials having deemed it an outbreak in 2019, transpired in the latter years of Trump's term, not Obama's. Biden succeeded Trump during the denouement of the pandemic.

Elsewhere in the speech, Biden referenced working with civil rights activists in his youth, and quipped that Detroit helped "put food on" his family's table, as his father, Joseph Biden Sr., was in the automobile business.

BIDEN DROPS EMBARRASSING GAFFES DAYS AFTER LIBERAL MEDIA HYPES SOTU PERFORMANCE

Reserving much of his remarks to criticize Trump, Biden claimed at one juncture that "MAGA Republicans" want to engage in book-banning and other endeavors he described as extremist.

"All that progress is at risk. Trump is trying to make the country forget just how dark things were when he was president," Biden said.

"We will never forget him lying about how serious the pandemic was, telling Americans just inject bleach I think that's what he did. I think that's why he's so screwy."

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In another jab, Biden warned against his predecessor potentially nominating more justices to the Supreme Court: "Do you think he'll put anybody [there] who has a brain?"

"It's clear when he lost in 2020, and I mean this sincerely: something snapped in Trump. He just can't accept he lost That's why Jan. 6 happened."

A mid-April Fox News Poll in Michigan found 46% of registered voters there support Biden, while 49% support Trump. Trump gained two percentage points in that survey over a similar one conducted in February. Two years prior, Biden led Trump by eight percentage points in the Great Lakes State.

Fox News Digital reached out to the White House for comment but did not receive a response by press time.

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Biden suggests he was vice president during COVID-19 pandemic: 'Barack said to me, go to Detroit' - Fox News

President Biden appeared to claim he was vice president during the coronavirus pandemic and that former President Barack Obama had dispatched him to Detroit to help with the response.

In comments first reported by the New York Post, Biden addressed an NAACP campaign event in Michigan Sunday night, where he repeatedly railed against his presumptive Republican opponent, former President Trump, while offering an aside about the contagion which began in 2019 while the latter was in office.

"When I was vice president, things were kind of bad during the pandemic," Biden said near the beginning of his remarks.

"And, what happened was Barack said to me: Go to Detroit help fix it."

BIDEN BIZARRELY ENDS CONNECTICUT SPEECH WITH GOD SAVE THE QUEEN, MAN

Going on to reference Detroit Democratic Mayor Mike Duggan, who was seated to Biden's right, the president continued, "Well, the poor mayor he's spent more time with me than he ever thought he's going to have to."

READ ON THE FOX NEWS APP

Duggan then rose and shook Biden's hand.

The pandemic, numbered COVID-19 due to global health officials having deemed it an outbreak in 2019, transpired in the latter years of Trump's term, not Obama's. Biden succeeded Trump during the denouement of the pandemic.

Elsewhere in the speech, Biden referenced working with civil rights activists in his youth, and quipped that Detroit helped "put food on" his family's table, as his father, Joseph Biden Sr., was in the automobile business.

BIDEN DROPS EMBARRASSING GAFFES DAYS AFTER LIBERAL MEDIA HYPES SOTU PERFORMANCE

Reserving much of his remarks to criticize Trump, Biden claimed at one juncture that "MAGA Republicans" want to engage in book-banning and other endeavors he described as extremist.

"All that progress is at risk. Trump is trying to make the country forget just how dark things were when he was president," Biden said.

"We will never forget him lying about how serious the pandemic was, telling Americans just inject bleach I think that's what he did. I think that's why he's so screwy."

In another jab, Biden warned against his predecessor potentially nominating more justices to the Supreme Court: "Do you think he'll put anybody [there] who has a brain?"

"It's clear when he lost in 2020, and I mean this sincerely: something snapped in Trump. He just can't accept he lost That's why Jan. 6 happened."

A mid-April Fox News Poll in Michigan found 46% of registered voters there support Biden, while 49% support Trump. Trump gained two percentage points in that survey over a similar one conducted in February. Two years prior, Biden led Trump by eight percentage points in the Great Lakes State.

Fox News Digital reached out to the White House for comment but did not receive a response by press time.

Original article source: Biden suggests he was vice president during COVID-19 pandemic: 'Barack said to me, go to Detroit'

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Biden suggests he was vice president during COVID-19 pandemic: 'Barack said to me, go to Detroit' - Yahoo! Voices

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The judge said only workers with no access to patients or colleagues made case for vaccine exemption

Published May 14, 2024 Last updated 18hours ago 4 minute read

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A nurse-practitioner who lost her job after refusing the COVID-19 vaccine on religious grounds was among 15 health-care workers who failed to have B.C. public health orders dismissed on constitutional and other grounds.

A B.C. Supreme Court ruled on three similar petitions to have two orders issued in 2023 by B.C.s provincial health officer thrown out, according to the reasons for judgment released Monday.

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The orders, issued in October 2023, extended a previous order requiring COVID vaccinations by workers in health-care settings and long-term care homes.

The health-care workers sought to dismiss the orders, arguing their continuation was an unreasonable exercise of the powers of the health officer, Dr. Bonnie Henry.

They argued the orders caused ongoing hardship and harm to workers who had lost their jobs and to the health-care system from the loss of personnel. About 1,800 health-care workers were fired for refusing to get vaccinated.

The petitions challenged the reasonableness of the orders on four grounds.

That, by late 2023, COVID was no longer an immediate and significant risk to public health and the health officers emergency powers no longer applied.

That there was no medical evidence that unvaccinated health-care workers posed a greater risk to vulnerable patients than vaccinated workers.

That it was unconstitutional to force the workers to choose between their fundamental and personal beliefs about vaccination and keeping their jobs, because it infringed on rights to freedom of conscience and religion in Canadas Charter of Rights and Freedoms.

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They also argued that it was unreasonable to apply the order to those who worked remotely or held administrative positions, given their lack of contact with vulnerable patients and front-line workers.

Justice Simon Coval dismissed the first three grounds. He agreed with the fourth one, ordering the issue be returned to the public health officer to tweak her health order.

And while he found the orders did violate Charter guarantees of conscience and religion, he ruled that infringement was reasonable because the health officer did not exceed what was necessary to balance the protection of vulnerable patients, residents and clients from serious illness and death and the safety of the public.

Peternella Hoogerbrug, the Christian nurse practitioner, was fired in May 2022 for refusing the vaccine for religious reasons.

She told court her faith is an integral and deeply held root part of her life and identity and her church, the Reformed Congregation in North America, opposes vaccination because it interferes with the providence of God and the church teaches placing ones trust in the vaccine, rather than God, can lead to idolatry, Coval wrote in his judgment.

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Hoggerbrug was devastated by losing her job to adherence to her faith and that providing health-care services has been a core aspect of her identity, according to the judgment. She hasnt been able to find a job as a nurse practitioner because of her lack of vaccination, it said.

York Hsiang, a vascular surgeon at Vancouver General, and David Morgan, a psychiatrist from Prince George, also lost their jobs because of their vaccine refusal.

Hsiang said he chose not to get the vaccine based on his own medically informed risk-benefit analysis and strong belief it should be his choice. He stopped performing surgery and retired in 2021 rather than face being fired.

Morgan, who assessed and treated youth in the criminal justice system, was fired in December 2021 for not getting the jab, and now works in private practice and as an assistant University of B.C. professor, the judgment said.

Hilary Vandergugten, a nurse who was a clinical coordinator at Langley Memorial Hospital, where she worked for 27 years, was fired in 2022, which affected her financially and emotionally. In her affidavit, she said she was working part-time doing COVID tests in the film industry.

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Other petitioners described severe consequences from losing their jobs for refusing the vaccine as they were terminated for just cause and were ineligible for severance or employment insurance benefits, and lost pension and insurance plans along with their jobs, the judgment said.

They had trouble replacing their jobs and some considered moving from B.C., Covals judgment said.

Coval wrote that Henrys job during a pandemic is to prevent and manage outbreaks, reduce risk of infection, serious illnesses and premature deaths, and protect the health-care system, and in October 2023 she issued the two orders, which had no expiry date.

Coval wrote that the petitioners argued that by October 2023 the continuation of the vaccination order was being used as a quasi-permanent precautionary measure for a virus which, by that time, the PHO herself described as no more serious than a cold.

But he said the 2023 orders are reasonable because health-care workers are in a special situation given the crucial role they play in the system and their near-constant, close contact with the most vulnerable patients, who generally speaking have no choice but to be treated by them.

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B.C. nurses, doctors fired over vaccine refusal lose court bid to toss health orders - Vancouver Sun

Covid-19 may have gone away but controversies over vaccine side-effects refuse to die. Covishield, the Covid-19 vaccine developed by UK-based drug major AstraZeneca and Oxford University and produced in India by Serum Institute of India, has triggered a big controversy in India with political parties too jumping in. There are demands for compensation for family members of people who died allegedly due to the vaccine side effects and to review the science behind all Covid vaccines.

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It all started with a submission made by Astrazeneva in a British court. It said in court documents that its Covid vaccine can cause a rare side effect, the UKs Daily Telegraph newspaper reported nearly 10 days ago. The pharmaceutical giant is being sued for over 100 million (a little over Rs 1,000 crore) in class action over claims its vaccine caused death and serious injury in 51 cases, according to court documents seen by the Daily Telegraph, a British newspaper.

AstraZeneca is contesting the claims but has accepted, in a legal document submitted to the high court in February, that its Covid vaccine can, in very rare cases, cause thrombosis with thrombocytopenia syndrome, which causes people to have blood clots and a low blood platelet count.

The India angle

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Venugopalan Govindan, father of Karunya, who died after taking the vaccine, said the admission by AstraZeneca is "too late" and has come after so many lives have been lost. " The parents have already filed a writ petition seeking compensation, appointment of an expert medical board independent of the government to forthwith inquire into and investigate the deaths of their daughter, and to share the report of the investigation with them.

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A plea has been filed in the Supreme Court, seeking setting up of an expert medical panel to study and assess the possible risk factors associated with the vaccine. It calls for a direction to the Centre to implement a vaccine damage payment system to compensate citizens who are severely disabled or deceased as a result of the vaccine.

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What is the chief concern?

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TTS is a rare yet serious condition linked to certain COVID-19 vaccines, notably adenovirus vector vaccines like AstraZeneca and Johnson & Johnson's Janssen vaccine. TTS is marked by the presence of blood clots (thrombosis) along with low levels of platelets (thrombocytopenia), crucial for blood clotting. It often involves unusual clot locations, such as in the brain (cerebral venous sinus thrombosis) or abdomen. Symptoms may include severe or persistent headaches, blurred vision, shortness of breath, chest pain, leg swelling, persistent abdominal pain, and easy bruising or tiny blood spots under the skin beyond the injection site.

While TTS is rare, individuals who have received vaccines associated with TTS should be vigilant for symptoms and seek medical attention promptly if they experience any within a few weeks of vaccination. Early recognition and treatment are essential for managing TTS effectively.

What AstraZeneca and SII say

"Our sympathy goes out to anyone who has lost loved ones or reported health problems," AstraZeneca has said amid concerns over the side-effects. "Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines."

The product information relating to the AstraZeneca vaccine was updated in April 2021, with the approval of the UK regulator MHRA, to include the possibility that the vaccine is capable, in very rare cases, of being a trigger for TTS. AstraZeneca points out this update was well documented and publicly available, The Telegraph reported. The vaccine, developed with Oxford University, is no longer used in the UK.

Benefits of the vaccine far outweigh the risks of extremely rare potential side effects, AstraZeneca has told news agency IANS. "From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile," the statement said. "Regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects," it added.

AstraZeneca has begun the global withdrawal of its COVID-19 vaccine, Vaxzevria, citing a surplus of available updated vaccines since the pandemic began. The company has also decided to withdraw the vaccine's marketing authorizations within Europe. "As multiple, variant COVID-19 vaccines have since been developed, there is a surplus of available updated vaccines," AstraZeneca stated. This surplus has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied."

SSI, the Indian manufacturer of AstraZeneca's vaccine under brand name Covishield, said on Wednesday that it had stopped manufacturing the vaccine and supply of additional doses in December 2021 itself. "With India achieving high vaccination rates in 2021 and 2022, coupled with the emergence of new mutant variant strains, the demand for previous vaccines diminished significantly, an SII spokesperson said. "Consequently, since December 2021, we have stopped the manufacturing and supply of additional doses of Covishield".

Moreover, SII also said that it had disclosed all rare and very rare side effects of the vaccine, including TTS, in the packaging inserts as well. "Regardless of whether it's AstraZeneca's Vaxzervria or our own Covishield, both vaccines have been instrumental in saving millions of lives worldwide. We commend the collaborative efforts of governments and ministries in facilitating a unified global response to the pandemic."

What experts say

"In spite of the uncommon risk of TTS, Covishield, which was used to vaccinate 90% of India's population, has done well in India," a senior member of the Covid working group told ET, downplaying worries of unfavorable outcomes.

Dr Kameshwar Prasad, emeritus professor of neurology at AIIMS, has told TOI that TTS is rare, but if it happens, it is usually serious, particularly when major vessels are involved in thrombosis. "We were members of a committee which developed a WHO guideline where the frequency of this condition has been estimated as less than 1 to 7 per lakh vaccines. Estimates of the risk of TTS following Covishield vaccination range from 1 case per 26,500 after the first doses of Covishield administered (reported in Norway) to 1 case per 261,000 doses of Janssen [vaccine] administered (reported in the US)," he said.

Dr Prasad said that TTS mostly occurs from day 3 to day 30 after the first dose of vaccine. "Beyond 30 days, there are very very few cases reported. If the first dose did not have this complication, its very unlikely that the second dose would cause TTS. In any case, after one month of vaccination, there is a negligible chance that TTS will develop, certainly after three months. Now that more than a year has passed since the last vaccine dose of Covid for most people from India, there is no need to worry about TTS," he said. He advised people not to hesitate to take vaccines rolled out by the government. "It is done after it is certain that the benefits outweigh the risks. Risks may not be more than moving on a road," he said.

The WHO has said that the recent epidemiological data suggests that the cumulative incidence of TTS is higher following the initial dose of the COVID-19 vaccine than subsequent doses.

Former Indian Council of Medical Research (ICMR) scientist R Ganga Ketkar, who was at the helm of affairs during the Covid pandemic, said symptoms of TTS - a serious adverse event that causes blood clots - can only occur within five to 30 days of receiving a Covid vaccine and not now. "The benefits of the vaccine outweigh the risks," Ketkar has told ET. "People should not worry as the number of cases are pretty small and TTS develops within 5-30 days after receiving the vaccine and not now." He said as the number of doses increases, the risk of TTS goes down.

A study conducted by physician-scientists from Assam Medical College Hospital (Dibrugarh), supported by ICMR-recognised multidisciplinary research laboratory, has revealed that 55% of Covishield vaccine recipients experienced only minor side effects like fever and headache. These symptoms occurred within a week of getting inoculated with the first dose. Researchers confirmed no long-term adverse effects after a year. In our study, we found that 55% experienced minor adverse events such as fever, headache, body ache and pain at the injection site. The remaining 45% of the recipients had no adverse events at all. After the second dose, only 6.8% showed minor adverse events following immunisation (AEFI). Most importantly, no participant showed any major adverse events during the entire one year period of study, associate professor of pathology at AMCH, Gayatri Gogoi, the principal investigator of the study done in Assams Dibrugarh district, has told TOI.

The study was conducted from July 2021 when the first Covishield vaccine for the public was introduced and participants were followed up till June 2022 after receiving the approval of the Institutional Ethics Committee to conduct the same. This data of research findings was recently accepted for publication in a well-known PubMed indexed journal named Journal of Family Medicine and Primary Care.

Besides experts, the government too has downplayed the frequency of the risks associated with the vaccine. Union Health Minister Mansukh Mandaviya said in March that ICMR has done a detailed study which shows that COVID-19 vaccine is not responsible for heart attacks, and an individual's lifestyle and factors such as binge drinking could be among underlying causes. "If someone has a stroke today, they think it is because of the Covid vaccine. ICMR has done a detailed study that the (Covid) vaccine is not responsible for heart attacks."

Amid the controversy over the side effects of the AstraZeneca vaccine, Bharat Biotech has asserted that its Covid-19 vaccine, Covaxin, is safe and devoid of any side-effects The company stated that Covaxin was developed with a single-minded focus on safety first, followed by efficacy. Covaxin is India's first indigenous Covid vaccine.

India's vaccine politics Political parties have questioned the government about the health concerns related to the vaccine. "The opposition Congress on Wednesday alleged that the BJP government at the centre did not follow the guidelines of the World Health Organisation (WHO), and demanded that the relatives of those who died due to heart attack or similar reasons after taking the Covishield vaccine against coronavirus should be paid compensation. Doctors associated with the Gujarat BJP, however, said a study by an expert panel in the state had established that there was no direct link between COVID-19 vaccines and blood clotting which can lead to heart attacks," PTI reported.

Samajwadi Party president Akhilesh Yadav Friday said the lives of the people of the country have been put in danger by the Covid vaccine and demanded that the heart-related tests like ECG should be made free for those who have taken the vaccine.

Months before the AstraZeneca controversy, Union minister Rajeev Chandrasekhar hit out at senior Congress functionaries, claiming that they kept pushing the case for foreign vaccines in India during the pandemic. His statement came days after Pfizer CEO Albert Bourla faced questions over the efficacy of the companys vaccines.

The minister claimed that Pfizer tried to bully India into accepting conditions of indemnity. Just to remind all Indians that Pfizer tried to bully the Govt of India into accepting conditions of indemnity. And Cong trio of Rahul, Chidambaram n Jairam Ramesh kept pushing foreign vaccines during Covid, he tweeted. According to the indemnity clause, the company could not be held responsible or prosecuted under Indian law in case of any severe side-effect or even death on taking their vaccine.

The Pfizer vaccine is not available in the country. India ran its massive vaccination campaign against Covid-19 with two key vaccines Covishield and Covaxin. Covishield is manufactured by the Serum Institute of India while Covaxin is manufactured by Bharat Biotech.

(With inputs from TOI and PTI)

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Good shot, bad shot: What you need to know about Covishield issue - The Economic Times

Amid the safety concerns over AstraZeneca's Covid vaccine Covishield and Vaxzevria, the pharmaceutical giant on Tuesday said it has initiated to withdraw its Vaxzevria vaccine globally, The Telegraph reported. The company, however, said the move is due to a surplus of available updated vaccines since the Covid-19 pandemic, adding that this has led to the decline in demand for the vaccine.

The Telegraph report added that AstraZeneca's application to withdraw the Vaxzervria vaccine was made on March 5 and came into effect on May 7.

Meanwhile, on Tuesday, the company also withdrew marketing authorisation for the vaccine within Europe, reported Reuters.

AstraZeneca's latest move comes days after the Anglo-Swedish drugmaker admitted in a legal document submitted that its Covid vaccines, in very rare cases, can cause Thrombosis Thrombocytopenia Syndrome (TTS) - a rare syndrome characterized by blood clots (thrombosis) and low platelet counts (thrombocytopenia).

However, it also noted that the syndrome can be detected, even if there is no vaccination, adding that expert testimony will be required to determine causation in every case.

Despite this, the company maintained that extensive clinical trial data and real-world evidence consistently support the vaccine's safety and efficacy. It also reaffirmed that the company's first priority is patient safety.

Our sympathy goes out to anyone who has lost loved ones or reported health problems. Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines, a spokesperson for AstraZeneca said in a statement last week.

The pharmaceutical company has been fighting a class action lawsuit against its Covid-19 vaccines, allegedly leading to several deaths across the world. It first began after a man, identified as Jamie Scott, filed a complaint against AstraZeneca, saying that he developed a blood clot and bleed on his brain, which left him with a severe brain impairment after injecting the vaccine.

Additionally, over 50 cases have been filed in the court against AstraZeneca over its vaccine effects.

The Telegraph earlier reported that AstraZeneca has admitted in court papers that its Covid vaccine, Covishield, can cause rare side effect. Covishield was developed by AstraZeneca and was produced by the Serum Institute of India.

The Supreme Court will soon hear a petition on the rare side effects associated with Covishield. While a hearing date has not yet been set, Chief Justice of India DY Chandrachud has acknowledged the petition demanding an expert panel to investigate the vaccine's side effects.

(With inputs from Reuters)

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AstraZeneca to withdraw Covid vaccine worldwide amid safety issues: Report - Hindustan Times

Karunya Venugopal, a 20-year-old, died in July 2021 after getting COVID-19 vaccine. Image Courtesy: X/@gvenugopalan

The bereaved parents of a young woman who died in July 2021 are planning to sue AstraZeneca and the Serum Institute of India (SII). They say their daughter passed away after taking the Covishield jab, manufactured by SII in India.

The development comes after reports surfaced about the British-Swedish pharmaceutical giant AstraZenecas admission in court documents in the United Kingdom that its COVID-19 vaccine, in rare cases, can cause Thrombosis with Thrombocytopenia Syndrome (TTS). AstraZenecas COVID jab was sold as Covishield in India.

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TTS is a rare condition that leads to blood clotting and low platelet count.

Lets take a closer look.

What happened?

In July 2021, Karunya Venugopal, a 20-year-old data science student, died a month after getting vaccinated, as per a Scroll report.

After being hospitalised for weeks, she passed away due to multisystem inflammatory syndrome.

She developed severe complications eight days after taking the vaccine and died after a month in spite of three weeks of tertiary care hospitalisation, her father, Venugopalan Govindan, told Economic Times (ET) in late 2022.

She had no pre-existing health conditions and was completely healthy prior to taking the vaccine, he added.

In November 2021, the health ministrys immunisation division, after its inquiry, classified Karunyas death as B1, which meant that the AEFI (adverse event following immunisation) had a temporal relationship with the vaccination, but there was insufficient evidence to prove it was caused by the vaccine.

Govindan approached the Supreme Court, seeking monetary compensation from the government and for creating a protocol for early detection and treatment of AEFIs.

In November 2022, the Centre told the apex court that the government could not be held liable to provide compensation for the deaths due to the administration of COVID-19 vaccines. The government had said it took substantial efforts to ensure a safe and effective COVID-19 vaccination drive, reported The Hindu.

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ALSO READ: AstraZeneca vaccines side effects. Why Covishield takers shouldnt worry

Karunyas parents mull suing SII

Now, after AstraZeneca accepted for the first time that its COVID-19 vaccine can cause TTS in rare cases, Karunyas parents are mulling taking SII to court, as per an ET report. Govindan said the pharmaceutical giants admission has come too late after so many lives have been lost.

AstraZeneca and SII should have stopped the manufacture and supply of these vaccines when 15 European countries either suspended or age-limited these due to deaths from blood clots that happened in March 2021, within a couple of months of the rollout of the vaccine itself, he told ET.

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Govindan also questioned the government and Covishield maker for not halting the rollout of the vaccine after data about its adverse effects emerged from around the world.

If sufficient remedies arent obtained, for the sake of justice and to prevent recurrence of this atrocity that was perpetrated in the name of public health, we will file fresh cases against any and all of those perpetrators because of whose actions the deaths of our children ensued, he was quoted as saying by ET.

Eight of the victims families have connected and I am echoing the common sentiments of all of us, Govindan said, as per NDTV.

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The first reports of a link between AstraZenecas COVID-19 shots and TTS surfaced in early 2021. Several European countries, including Denmark, even stopped the use of the vaccine over these concerns for a while.

Another death after taking Covishield

Rithaika Sri Omtri, 18, got the first dose of Covishield in May 2021 in Hyderabad. As per a Scroll report, within five days of being vaccinated, she experienced a prickling sensation in her fingers and, later, a high fever.

As her fever did not subside for a few days, a doctor suggested her a blood test which revealed her platelets had dropped to a dangerous low of 40,000 per cubic millimetre, compared to a normal range between 1.5 lakh and 4 lakh.

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Over 10 days later, Rithaika started vomiting and could not walk. An MRI scan of her brain showed that she had multiple blood clots and a haemorrhage in the right frontal region, Scroll reported.

Despite efforts to save her, she was declared brain dead, two weeks after her vaccination.

As per Scroll, Rithaika had suffered a vaccine-induced (immune) thrombotic thrombocytopenia or VITT, a rare adverse effect that leads to blood clots and low platelet count.

VITT was reported in some people who got adenoviral vector COVID-19 vaccines such as AstraZenecas Vaxzevria (marketed as Covishield in India) and Johnson & Johnsons Janssen shots.

A probe by the AEFI committee categorised Rithaikas death under the A1 cetagory, meaning a vaccine product related reaction, reported ET.

Rithaikas mother, Rachana Gangu, was the second petitioner, who along with Govindan, had moved the apex court in late 2021, alleging her child died due to severe complications after getting the first dose of the COVID-19 vaccine.

In her writ petition, she had demanded compensation and the establishment of an expert medical board to inquire and probe her daughters death.

The cases in UK

AstraZeneca is being sued in a class action in the UK High Court over claims that its COVID-19 vaccine, developed with the University of Oxford, caused death and serious harm in 51 cases.

Victims and grieving relatives are seeking damages estimated to be valued up to 100 million pounds.

The first case against the pharmaceutical giant was filed last year by Jamie Scott, who was left with a permanent brain injury after suffering from a blood clot and a bleed on the brain. This happened after he got the vaccine in April 2021 and Scott has been unable to work since then, The Daily Telegraph reported.

While AstraZeneca is contesting the claims, it has accepted, in a legal document submitted to the High Court in February that its COVID vaccine can, in very rare cases, cause TTS, the report added.

With inputs from agencies

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AstraZeneca, Serum Institute to be sued by parents of woman who died after Covishield jab: What happened? - Firstpost